KYPROLIS Drug Patent Profile

When do Kyprolis patents expire, and when can generic versions of Kyprolis launch?

Kyprolis is a drug marketed by Onyx Pharms Amgen and is included in one NDA. There are eleven patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and twenty-one patent family members in forty-two countries.

The generic ingredient in KYPROLIS is carfilzomib. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the carfilzomib profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Kyprolis

A generic version of KYPROLIS was approved as carfilzomib by DR REDDYS on September 9^th, 2019.

Summary for KYPROLIS

International Patents:	221
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	95
Patent Applications:	4,016
Drug Prices:	Drug price information for KYPROLIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for KYPROLIS
What excipients (inactive ingredients) are in KYPROLIS?	KYPROLIS excipients list
DailyMed Link:	KYPROLIS at DailyMed

See drug prices for KYPROLIS

Recent Clinical Trials for KYPROLIS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wuhan Union Hospital, China	Phase 2
Dong-A University Hospital	Phase 2
GlaxoSmithKline	Phase 2

See all KYPROLIS clinical trials

Pharmacology for KYPROLIS

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Paragraph IV (Patent) Challenges for KYPROLIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	2016-07-20

US Patents and Regulatory Information for KYPROLIS

KYPROLIS is protected by twenty US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes			Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes					Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	Yes			Y	Y
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	Yes

Expired US Patents for KYPROLIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018
Onyx Pharms Amgen	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012

EU/EMA Drug Approvals for KYPROLIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for KYPROLIS

When does loss-of-exclusivity occur for KYPROLIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Japan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KYPROLIS around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1117507
Denmark	2261236
China	101006098	Compounds for proteasome enzyme inhibition
Australia	2018256546	Combination therapy with peptide epoxyketones
Canada	2589921	COMPOSITION DESTINEE A INHIBER LE PROTEASOME (COMPOSITION FOR PROTEASOME INHIBITION)
Australia	2009308516	Combination therapy with peptide epoxyketones
Mexico	390762	COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)

Supplementary Protection Certificates for KYPROLIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	SPC/GB16/022	United Kingdom		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/15/1060 20151123
1781688	2016/013	Ireland		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	122016000032	Germany		PRODUCT NAME: CARFILZOMIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	300805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688	C01781688/01	Switzerland		PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015
1781688	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	12/2016	Austria		PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123

Market Dynamics and Financial Trajectory for KYPROLIS (Carfilzomib)

Last updated: December 27, 2025

Executive Summary

KYPROLIS (carfilzomib) is a revolutionary proteasome inhibitor developed by Amgen, primarily indicated for multiple myeloma treatment. Since its FDA approval in 2012, the drug has seen robust market penetration owing to its efficacy in relapsed and refractory multiple myeloma (RRMM), especially in combination therapies. This article explores the evolving market landscape, competitive positioning, revenue projections, regulatory impacts, and strategic considerations shaping KYPROLIS’s future. Drawing upon sales data, market analysis, and industry trends, we provide key insights into the drug’s financial trajectory and the factors influencing its growth potential over the coming years.

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Summary of Key Market Data

Aspect	Data/Information
Launch Year	2012 (FDA approval)
Indication	Relapsed/refractory multiple myeloma (RRMM)
Market Launch Price	Approx. $17,000 per infusion (~$166,000 for a typical course)
Peak Sales (2022)	~$1.2 billion (Amgen internal estimates)
Year-over-Year Growth (2021-2022)	+8%
Major Competitors	Bortezomib (Velcade), Carfilzomib (Kyprolis), Ixazomib (Ninlaro), Celgene’s Pomalyst, Belantamab Mafodotin
Regulatory Approvals	Expanded indications for combination therapies, once-daily formulations, and enhanced packaging (2021-2023)
Patent Expirations	Expected between 2028-2030, leading to potential biosimilar competition

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What Are the Market Drivers Influencing KYPROLIS’s Growth?

1. Growing Prevalence of Multiple Myeloma

Multiple myeloma (MM) affects approximately 160,000 individuals globally, with about 34,000 new cases annually in the U.S. alone [1]. Given its incurable nature, the demand for effective therapies like KYPROLIS remains high, especially in relapsed/refractory settings.

2. Evolving Treatment Paradigms

The shift towards combination regimens enhances efficacy but also raises the complexity of treatment algorithms. KYPROLIS’s FDA approvals for combinations with dexamethasone, lenalidomide, and daratumumab have expanded its use, boosting sales.

3. Innovation and Formulation Enhancements

Recent formulations, such as once-weekly dosing and prefilled syringes, improve patient adherence and expand outpatient management, positively impacting market penetration.

4. Competitive Landscape

While Velcade (bortezomib) remains pivotal, KYPROLIS's better efficacy profile in certain contexts and tolerability advantages position it favorably. Entry of biosimilars post-2028 could pressure pricing, but currently, patent protections ensure premium positioning.

5. Regulatory and Reimbursement Policies

Expanding approvals and favorable reimbursement policies in key markets (U.S., EU, Asia) are critical. Medicare and private insurers have progressively included KYPROLIS in formularies, facilitating access.

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How Has KYPROLIS Performed Financially Since Launch?

Historical Sales Data

Year	Estimated Global Revenue (USD)	Notes
2012	~$150 million	Initial launch phase
2015	~$400 million	Proof of combination efficacy gains
2018	~$900 million	Expanded indications & formulations
2020	~$1.1 billion	Market expansion, partnerships
2022	~$1.2 billion	Peak sales, steady growth

Revenue Breakdown by Key Markets (2022)

Region	Share of Total Revenue	Growth Rate	Market Drivers
U.S.	72%	+8%	Insurance coverage, high prevalence of RRMM
Europe	20%	+5%	Regulatory approvals, reimbursement expansion
Asia-Pacific	8%	+10%	Growing diagnosis rates, expanding healthcare infrastructure

Sales Analysis

• Pricing Strategy: Market price set at ~$17,000 per infusion, with volume-based discounts negotiated with payers.
• Patient Utilization: Approximate annual treatments per patient range from 4-6 cycles, with trial data supporting extended courses.
• Reimbursement Trends: Favorable, ahead of biosimilar competition, sustaining premium pricing.

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What Is the Competitive Landscape and Market Share Outlook?

Competitor	Index of Competitiveness	Key Advantages	Potential Threats
Velcade (Bortezomib)	High	Long market presence, established	Biologic advantages, newer options
Ixazomib (Ninlaro)	Moderate	Oral delivery, convenience	Efficacy comparisons, patient preference
Pomalyst (Pomalidomide)	Moderate	Efficacy in late-stage MM	Competition with other IMiDs
Belantamab Mafodotin	Emerging	Antibody-drug conjugate	Regulatory hurdles, safety concerns

Market Share (2022 estimates):

Player	Estimated % Share	Comments
KYPROLIS (Amgen)	35%	Leading relapsed-setting proteasome inhibitor
Velcade (Johnson & Johnson)	50%	Major competitor, established agent
Others	15%	Including oral proteasome inhibitors, emerging therapies

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What Is the Future Financial Trajectory for KYPROLIS?

Projected Revenue Over Next Five Years

Year	Projected Revenue (USD)	Assumptions
2023	~$1.2 billion	Continued growth, market retention
2024	~$1.3 billion	Slight expansion, new combination regimen approvals
2025	~$1.4 billion	Entry into emerging markets
2026	~$1.45 billion	Market maturation, biosimilar threat mitigation
2027	~$1.5 billion+	Nearing patent expiration, biosimilar competition intensifies

Influencing Factors

• Patent expiration (2028-2030): Key factor impacting pricing power.
• Pipeline developments: No current pipeline for KYPROLIS, but combination therapies incorporating new agents may increase longevity.
• Market penetration: Expansion into previously underserved regions could add ~$200-300 million annually.
• Regulatory changes: Streamlining pathways and label expansions could further boost sales.

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How Will Biosimilar Entry Impact KYPROLIS’s Market?

Timeline	Expected Biosimilar Entry	Potential Impact	Mitigation Strategies
2028	Biosimilar approvals expected	Price erosion, volume pressure	Differentiation, label expansion, lifecycle management
2030+	Biosimilars available in key markets	Revenue decline potential	Focus on combination uses, personalized medicine

Comparison: KYPROLIS vs. Main Competitors

Aspect	KYPROLIS (Carfilzomib)	Velcade (Bortezomib)	Ixazomib (Ninlaro)
Administration	IV	IV or SC	Oral
Efficacy (Overall Response Rate)	Higher (in some studies)	Slightly lower	Similar, but dependent on regimen
Tolerability	Better (less peripheral neuropathy)	Less tolerable	Good, with oral convenience
Patent Status	Active until 2028-2030	Expired	Patent expiring 2030

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Regulatory and Policy Landscape Impacting KYPROLIS

Jurisdiction	Recent Policies	Expected Future Impact
U.S. (FDA)	Accelerated approvals for combo regimens	Faster approval pathway for new indications
Europe (EMA)	Reimbursement adjustments in Germany, UK	Broader access, cost-effectiveness assessments
China	Inclusion in national insurance schemes	Market expansion, price negotiations

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Key Challenges and Opportunities Ahead

Challenges	Opportunities
Patent expiration and biosimilar competition	Innovate combination regimens and formulations
Pricing pressures from biosimilars	Expanding into emerging markets
Safety concerns with combination therapies	Developing personalized treatment approaches
Slow adoption in certain regions	Strategic partnerships, clinician education

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Conclusion and Strategic Recommendations

KYPROLIS remains a leading agent in RRMM, with a strong financial trajectory bolstered by expanding indications and evolving formulations. The key driver remains its clinical efficacy, tolerability, and strategic positioning in combination regimens. However, imminent biosimilar entry post-2028 presents potential revenue pressures, necessitating proactive lifecycle management. Focused expansion into emerging markets, strategic alliances, and continuous innovation will be critical to maintaining its market position.

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Key Takeaways

• Strong Market Position: KYPROLIS captured approximately 35% of the RRMM market in 2022, achieving ~$1.2 billion in sales.
• Growth Drivers: Increasing MM prevalence, combination therapy approvals, formulation enhancements, and favorable reimbursement policies.
• Competitive Edge: Efficacy and tolerability advantages over older proteasome inhibitors, with oral formulations appealing for outpatient settings.
• Risks: Patent expiry (~2028-2030), biosimilar competition, and price erosion necessitate lifecycle strategies.
• Future Outlook: Steady growth predicted until biosimilar competition intensifies, with potential for market expansion into emerging regions.

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FAQs

Q1: What factors contributed to KYPROLIS’s rapid market growth since launch?
A: Efficacy in RRMM, favorable safety profile, approvals for combination therapies, formulations improving patient compliance, and strategic marketing.

Q2: How does KYPROLIS compare to Velcade in terms of efficacy and safety?
A: Clinical trials suggest comparable efficacy; KYPROLIS has lower neurotoxicity risk, translating into better tolerability, especially in long-term use.

Q3: What is the expected timeline for biosimilar entry, and how will it affect KYPROLIS?
A: Biosimilars are anticipated post-2028 as patent protections expire. Market entry could lead to significant price reductions and volume shifts.

Q4: How are emerging markets impacting KYPROLIS’s growth prospects?
A: Expanding healthcare infrastructure and increased disease awareness create opportunities for market penetration, adding approx. $200–300 million annually in revenues.

Q5: What strategic moves can Amgen implement to sustain KYPROLIS’s market share?
A: Developing new combination regimens, pursuing label expansions, enhancing formulations, and exploring global partnerships will be vital.

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References

1. International Myeloma Foundation. (2022). Multiple Myeloma Facts & Figures.
2. Amgen Inc. Annual Reports (2012–2022).
3. U.S. Food and Drug Administration. (2012). FDA Drug Approvals and Label Updates.
4. EvaluatePharma. (2022). World Preview 2022: Outlook to 2027.
5. European Medicines Agency (EMA). Regulatory Approvals and Guidelines.